It is widely accepted that existing legislation needs to be improved in order to meet public concern in Europe about the potential impact of chemicals on health and the environment.

A review of the existing legislation identified a number of shortcomings that need to be addressed. For example, it does not make sufficient information available about the properties of "existing" chemicals (first marketed before 1981) which dominate the Community market, it does not deliver risk assessments within a reasonable timeframe, and it placed too much onus on public authorities to provide proof of risk. The fact that the requirements for putting new chemicals on the market are much stricter than the current rules applied to existing chemicals acts as an impediment to innovation.

The Council of Ministers and the Parliament clearly favour development of more effective mechanisms and procedures which would place a greater onus on industry to make available information on the hazards, risks, and risk reduction measures for chemicals currently in use, and which would create greater confidence that dangerous substances were being used safely. Industry has welcomed the new policy orientation, broadly agreeing that companies should be given greater responsibility for the safety of the chemicals they produce, provided the competitivness of the EU industry can be maintained.

What is the legal base of the new policy?

The legal base of the new policy will be Article 95 of the EU Treaty in keeping with the objective of safeguarding the internal market, while ensuring a high level of health, safety, consumer and environmental protection. The precautionary principle will continue to guide the approach in the implementation of necessary measures.

What are the overall aims of the new chemicals strategy?

In the White Paper on the Strategy for a Future Chemicals Policy (COM (2001) 88) the Commission outlined the strategy to ensure a high level of chemicals safety through a system for Registration, Evaluation and Authorisation of Chemicals to be known as the REACH system.

The White Paper is based on seven objectives that need to be balanced within the overall framework of sustainable development:

Protection of human health and the environment

Maintenance and enhancement of the competitiveness of the EU chemical industry

Prevention of fragmentation of the internal market

Increased transparency

Integration with international efforts

Promotion of non-animal testing

Conformity with EU international obligations under the WTO.

The new REACH system should put Europe well in advance of most other countries in terms of the health and safety guarantees provided by manufacturers and importers of chemicals.

How will REACH work?

The main features of REACH

Registration: the main element of REACH. Manufacturers and importers will demonstrate in a registration dossier that they are managing their chemical substances safely. Companies will be required to register all substances produced or imported in volumes of 1 tonne and more per year per manufacturer or importer in a central database run by an independent agency to be created. Information requirements will largely depend on volume, but may be tailored based on intrinsic properties and conditions of use. Registration will involve providing information on, among other things:

The intrinsic properties and hazards of each substance (such as physico-chemical, toxicological and eco toxicological properties). Animal testing is to be kept to a minimum and costs reduced by sharing existing data.

The use(s) for which the substance is intended and information on whether/ how it may come into contact with people and/or the environment (known as the exposure scenario)

An assessment of risks for human health and the environment

A statement on how the producers or users are managing the risks associated with the use(s) of the substance.

For low volume chemicals (less than 100 tonnes/year) that do not raise concerns, registration alone will be sufficient. It is expected that around 80% of all substances will only have to be registered. All substances produced in higher volumes will be subject to evaluation. Evaluation will also be used for substances of concern, e.g. if there are indications that they may cause serious chronic effects.

To cope with the large number of the existing substances a phased approach is proposed with deadlines for registration set according to the volume of the substance on the market or hazard (eg substances on the market above 1000 tonnes, and all CMR substances above 1 tonne, to be registered within 3 years).

Evaluation: the registration data will be examined by the Competent Authorities of the Member States. Standard evaluation is compulsory for substances on the market above 100 tonnes and mainly aims at reducing animal testing.

Member states also have the opportunity to evaluate any substance (make a priority evaluation) and may ask for additional information or testing if they have any concerns about the potential risks posed by the substances or the quality of the registration dossier.

Authorisation: the most hazardous substances will be controlled by requiring an authorisation for their use. This authorisation will permit specific uses under certain conditions. Companies applying for an authorisation will have to demonstrate that they can adequately control the risks posed by the chemical substance or that the social and economic benefits of the substance outweigh the risks. The possibility for substitution will also be considered.

Examples of substances that will be subject to authorisation are those expressing certain characteristics: CMRs (carcinogenic, mutagenic or toxic to reproduction, all cat. 1 or 2), PBTs (persistent, bio-accumulative and toxic), vPvBs (very persistent, very bio-accumulative). Endocrine disrupting substances and other substances that give rise to similar levels of concern will be subject to authorisation on a case by case basis.

Restrictions are the safety net of the system. It will give the possibility to introduce restrictions at EU level on any substance that poses unacceptable risks, taking due account of socio-economic factors.

Scope of REACH

All chemical substances produced or imported in volumes of 1 tonne or more per year, per manufacturer/importer, have to be registered in REACH. There are special provisions for intermediates and polymers.

Certain intermediates (chemical substances that are used to make other chemical substances) will have to be registered but with simplified information requirements commensurate with their reduced risk.

Certain polymers will be subject to a reduced registration requirement. Non-hazardous polymers will be exempted.

Preparations(mixtures of chemicals such as paint):As the REACH system is substance based, it is the substances in preparations that will need to be registered, not the preparations themselves.

Articles (e.g.shoes or textiles): where an article releases significant amounts of hazardous substances during normal use or disposal, the producer/ importer will need to register the substance in the REACH system if it is not already registered.

Deadlines

Substances that are already on the market will be phased gradually into REACH. Substances produced in high volumes and CMRs will have to be registered first. Registration deadlines will be calculated from the year the legislation enters into force so that the new obligations will apply from

year 3 for high production volume chemicals (1,000 tonnes or more/year/ manufacturer or importer) and CMRs in lower volumes;

year 6 for production volumes in the range of 1001,000 tonnes; and

year 11 for low production volume chemicals (1100 tonnes).

How will REACH complement other community legislation?

The REACH legislation has been drafted to avoid overlaps with other legislation.

What is the difference between REACH and the present system for chemicals' management?

Under the present legislation Public Authorities are required to identify and address possible safety issues for the chemicals on the market.

REACH aims to change this balance by requiring industry to take responsibility for assessing the risks of chemicals and to put in place adequate risk reduction measures.

At the same time improvements in the efficiency of the system are designed to ensure that there are better incentives for developing new and safer chemicals and that rules are drawn up in such a way that the competitiveness of the industry is safeguarded.

The transparency of REACH gives downstream users, workers, professional users, consumers and others the information they need.

Comparison between the present system and REACH

Present system

REACH

There are gaps in our knowledge about many of the chemicals on the European market.

REACH will close the knowledge gap by providing safety information about all chemicals produced or imported in volumes higher than 1 tonne/year per manufacturer/importer.

The 'burden of proof' is on the authorities: they need to prove that a use of a chemical substance is unsafe before they may impose restrictions.

The 'burden of proof' is on the industry. It has to be able to prove that the way it intends to use a chemical substance is safe. All actors in the supply chain will be obliged to assess and implement measures to ensure the safety of the chemical substances they handle.

Registration requirements start at a production level of 10 kg. At 1 tonne, a series of tests including animal tests, have to be undertaken.

Registration is only required when production/import reaches 1 tonne. As far as possible, animal testing will be minimised.

It is relatively costly to introduce a new substance on the market. Cheaper, and maybe untested, existing chemicals are often used rather than developing new substances.

Innovation of safer substances should be encouraged under REACH.

Public Authorities are obliged to perform comprehensive risk assessments which are slow and cumbersome.

Industry has the responsibility to assess the safety of the intended uses, prior to production and marketing. Authorities will focus on issues of serious concern.

Who will do what under REACH?

Division of responsibilities

'

Industry

Agency

Member States

Commission

Registration

Data submission. Risk assessment and risk management measures.

Updating registration when they have new information.

Proposal on testing schemes.

Depository of registration dossiers.

Completeness check.

Data base maintenance and information to the public.

Decision on rejection of registration dossiers and follow-up.

Enforcement

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Evaluation

Providing further information if required.

Co-ordination of work, support decision-making

Review of individual dossiers and decide on further information requirements through agreement procedure

The Member States Competent Authorities will be responsible for evaluations of the substances of particular concern. They can initiate the procedure for restrictions, can grant authorisations for local uses of high concern substances and will enforce the new system within their territory.

The Agency, to be funded mainly through fees charged for registrations and authorisations, will act as the central point in the REACH system. It will run the databases necessary to operate the system and organise the evaluation procedures, provide essential advice to the Commission on priorities regarding treatment of substances and on issues linked to authorisation. It will also run a number of technical committees advising the Commission.

The Commission will oversee the work of the Agency, and will finally decide on evaluation if Member States fail to reach an agreement. It will also decide on authorisations and restrictions of uses of specific substances following risk assessment. 6.2. Role of the industry

The new legislation addresses manufacturers, distributors, importers and downstream users.

The manufacturers are those that produce substances. Importers import substances from non-EU countries. And downstream users are those that make industrial or professional use of chemicals. Some of them mix chemicals to make preparations (such as ink), others use substances or preparations to make articles (such as ballpoint pens, chairs or cars), or use them otherwise in their business (such as CD-manufacturers using degreasing agents to clean their machines).

The majority of the REACH requirements apply directly to manufactures and importers of substances. They will supply data on the properties of their chemicals, develop safety assessments as well as risk reduction measures.

Downstream users will obtain safety information about the chemicals that they purchase. They will need to make sure that their customers (eg other industries and consumers) can use their products safely. When a chemical is to be used in a way not foreseen in the original registration, the new uses or risk reduction measures will have to report them to the Agency.

How will REACH promote innovation and development of safer substitutes?

To help maintain competitiveness, one of the objectives of REACH is to promote R&D and innovation.

For example:

Uses of substances in product or process oriented R&D do not need to be registered for up to 5 years (renewable for a further 5 years).

The REACH threshold for registration (1 tonne/year) is much higher than the current 10 kg threshold for new substances.

The requirements for authorisation should encourage companies to increase their search for finding safer substitutes.

The discrimination of new substances versus existing substances will come to an end.

How does the Commission propose to keep animal testing to a minimum?

REACH will mean large-scale collection of information but not necessarily large-scale testing.

To minimise animal testing, information requirements have been trimmed to enable smart and targeted testing, which takes into account the likely exposure by the use(s) of the substance to enable an adequate risk management.

Registrants will not necessarily need to do new testing to register. They can make use of other information available such as studies from other countries, previous animal testing, available in vitro data, epidemiological studies etc.

For low volume chemicals (1-10 tonnes/year per manufacturer or importer), as far as possible animal testing will be avoided. For higher volumes, animal testing may be necessary if existing information and validated alternative methods are not sufficient.

Testing programmes involving animals, required for certain higher volume substances need to be agreed with the competent authorities before the experiments start, to ensure that the endpoints studied are relevant, that the scientific validity of the research is sufficiently high, and finally to ensure that the testing programme is not duplicating other studies.

To minimise duplicate testing, data sharing between enterprises will be encouraged.

How will the sustainable development objectives be achieved ?

In the course of preparation of the legal texts special care has been taken to design the requirements in such a way as the required balance between the three pillars of sustainable development will be assured. The essential goals have been:

to ensure that the system delivers significant improvements to health and the environment, for example, by bringing within the scope of the authorisation system all substances of high concern, by ensuring that non-confidential data is made available to the public and to downstream users, and by encouraging the development of safer chemicals;

to encourage research and innovation, to reduce costs to enterprises, especially SMEs, and to minimise the impact on competitiveness.

The proposals meet the sustainable development challenge in a number of ways.

To help ensure that human health and the environment are protected, measures taken include:

bringing within the scope of authorisation substances which are category 1 and 2 carcinogens, mutagens and reproductive toxicants (CMRs), persistent bioaccumulative and toxic (PBTs), very persistent very bilaccumulative (vPvBs), and those which are demonstrated to give rise to an equivalent level of concern (e.g. endocrine disruptors, certain sensitisers);

establishing information requirements that enbale PBTs and vPvBs to be identified;

enabling Member States (MS) to carry out detailed evaluations of the information on registered substances and to request further information if necessary;

putting the onus on enterprises to demonstrate that their substances can and will be used safely.

To help ensure the competitiveness of EU industry, measures taken include:

simplifying registration requirements for low tonnages. This willl, in particular, help many small andmedium sized enterprises (SMEs);

encouraging joint registrations by a number of enterprises, reducing costs for information generation and on registration fees;

allowing the information required to be generated in a wide number of ways, not always requiring expensive testing. Certain information will not be required at all if the likely exposure does not justify it.

introducing information requirements for many polymers and intermediates that are considerably less than for other substances, because the risks they pose are likely to be low, given their chemical structure and their use respectively;

encouraging innovation by allowing research and development to take place without registration for 5 years, extendable to 10; this is a considerable extension of existing provisions.

How will REACH affect industry?

Costs for registration

Testing costs:The Business Impact Assessment (BIA) estimates the total direct registration and testing costs that will have to be borne by industry at €1.47 billion; €3.6 billion is the most likely estimate.

According to estimates made by the Commission's services, in addition to these direct costs, the indirect costs to manufacturing industry and to society as a whole has been estimated in the range of €14-€26 billion up to 2020. The Commission will, of course, present a final impact assessment based on input from the internet consultation once the final proposal is presentedImpact on innovation and competitiveness:the more attractive incentives provided for the development of new substances (see question 6), and the careful design of the new system, are expected to have a positive effect on innovation and to safeguard competitiveness.

Data sharing:all registrants for the same substance will be encouraged to refer to the same data. When registrants are required to share data (i.e. to avoid duplicate animal testing), costs should be shared in a fair way between the registrants.

Impact on SMEs

Small and medium sized enterprises (SME) are an important part of the EU chemicals industry. Since safety is a key concern, regardless of company size, the REACH information requirements relate to production volumes, uses and properties of the chemicals, and not to turnover or the number of employees of the companies.

Many of the SMEs that will be affected by the present legislative proposal are 'downstream users', that is companies that buy chemicals and use them as ingredients in their own products or use chemicals in an industrial or professional way. As a result of their position in the value added chain, most chemicals will already be registered when they are utilised by downstream users. Most of the ways in which the chemicals will be used will be covered by the safety assessments carried out by the registrants. This will help to ensure a high level of chemical safety for downstream users.

SMEs that are manufacturers will be able to take advantage of the incentives for innovation that the REACH system will create, such as:

Exemptions from testing requirements for substances used in scientific or product- and process- orientated research and development.

Light information requirements for low volume substances that do not fall under authorisation (registration threshold at 1 tonne/year per manufacturer/importer, normally only in vitro testing for substances between 1 and 10 tonnes). This should reduce the costs for manufacturing SMEs, who will typically work in this range.

Administrative burdens and costs can partly be shared between registrants in the pre-registration process.

Loss of substances

Downstream users have voiced fears that some substances would not be registered because manufacturers will not consider it worthwhile to pay the cost of registration.

Due to the dynamic nature of the market for chemicals, it is difficult to imagine that essential chemicals will disappear without being substituted. The REACH system will act as a spur to innovation, by encouraging companies to develop substitute products for some of those substances which otherwise might need to go through the authorisation process.

What are the main advantages of REACH?

The benefits of the REACH system are twofold: risks to human health will be reduced and environmental quality will be improved through the better and earlier identification of the properties of chemical substances and through the new framework for registration, assessment, and authorisation of chemical substances. These impacts are difficult to estimate in monetary terms and are being subjected to further study. Further significant benefits are expected as a result of improvements in general health, in addition to benefits for the environment.

The identification of hazards and better management of risks resulting from the use of chemicals will contribute to the prevention of health problems caused by exposure to chemicals, e.g. lower occurence of diseases and preventable deaths, and lower costs for the national health systems.

The European chemicals industry will benefit from a single EU regulatory system, decision making with set deadlines and a high quality image for their products.

Downstream users of chemicals will get relevant information on the safe use of each chemical substance they buy. They will have closer contacts with their suppliers, and will be able to ensure better protection of their workers. Their products will be safer for consumers and the environment.

Based upon the results of an independent study conducted to evaluate the impact of REACH in the occupational health area(1), the likely occupational health benefits are estimated at between €18 and €54 billion over a 30-year period.

What consultation has taken place/will take place before adoption?

Before and during the entire process of drafting the new legislation, the Commission has had extensive information contacts with Member States, third countries, industry and NGOs, both informally and through many working groups.

Member States: Regular contacts through meetings with the competent authorities. Several Member States participated in Technical Expert Working Groups. A number of Member States provided position papers.

Third countries: Position papers, "non-papers" and letters highlighting the views of third countries or third country associations were received and many meetings and discussions took place.

Industry: Many industrial associations representing different branches of industry submitted position papers on the chemicals strategy. Bilateral meetings and participation in different conferences organised by industry allowed for a regular exchange of views. Experts nominated by different industrial organisations participated in the Technical Expert Working groups.

NGOs: Environmental, consumer and animal welfare NGOs have all submitted position papers on the chemicals strategy. Major environmental NGOs and the European Consumers Organisation (BEUC) were invited to competent authorities meetings. The animal welfare groups have had opportunities on several occasions to voice their concerns related to animal testing, including at the meetings of the Commission with Member State Competent Authorities for the protection of experimental animals. Experts nominated by several of the NGOs have participated in the Technical Expert Working groups.

What are international initiatives in the area of chemicals safety?

As chemical substances are traded internationally, chemical safety is a global concern, which is shown by the number of international initiatives in this area.

United Nations Environment Programme (UNEP): A strategic approach to international chemicals management is under development, (a high-level multi-sector conference is scheduled in late 2005). The World Summit on Sustainable Development in Johannesburg in September 2002 agreed that by 2020 chemicals should be used and produced in ways that minimise significant adverse effects on human health and the environment.

The OECD has initiated a co-operative action programme for testing and assessing High Production Volume (HPV) chemicals in a systematic way. When important data gaps are identified or concerns are raised, further investigation, in-depth assessment or risk assessment measures are recommended.

Several international conventions have been adopted, aiming at reducing the risk connected with chemicals. These include the Rotterdam Convention on Prior Informed Consent (PIC), which sets up a system for controlling trade in certain dangerous substances. The PIC convention was signed by the European Community in 1998 and was ratified 20 December 2002 by the Community. Six Member States have already signed the convention as well.

The Stockholm Convention on Persistent Organic Pollutants (POPs) sets out to control the production, use, import, export, disposal and releases of twelve POPs. The convention bans deliberate production and use of POPs and development of new POPs, and also aims at minimising releases of unintentionally produced POPs. The POPs convention was signed by the European Community and the Member States in 2001 and has not yet been ratified.

The Commission takes an active part in the ongoing negotiations on a GlobalHarmonised System (GHS) for the classification and labelling of chemicals. It participates in the Intergovernmental Forum on Chemicals Safety (IFCS), a forum where governments and intergovernmental and non-governmental organisations meet. IFCS aims to promote chemical risk assessment and the environmentally sound management of chemicals.

Is the REACH proposal WTO compatible?

The WTO rules allow members to set in place measures for the protection of public health that they deem appropriate, as long as these protective measures are non-discriminatory towards other members. They also require that the rules to be established should be proportionate to the objectives prescribed. The REACH system has been designed to put EU and non-EU producers of chemicals on an equal footing thus the requirements for imported chemicals and chemicals manufactured within the EU are the same. The REACH system also takes into account comparable non-EU data- and test-results on chemicals, especially those resulting from internationally recognised tests. The requirements set down are the minimum necessary to ensure that the health and safety objectives established can be achieved, every effort having been made to reduce the costs and burdens of the system.

Glossary and abbreviations

Agency: A central Agency will be in charge of the day to day management of REACH.

Animal testing: Testing carried out on research animals, mainly mice and rats, in order to predict the potential negative effects of a substance in humans or animals.

Article: Manufactured product that has a final shape that is related to its use (example: car).

Authorisation: Use-specific permission to use substances of very high concern.

Business impact assessment (BIA): Study carried out for the Commission to estimate the costs of REACH.

CMR: Substance of very high concern which is carcinogenic (causes cancer), mutagenic (causes damage to genes) or reproductively-toxic (causes either a decrease in fertility or problems with development of the foetus). CMRs category 1 and 2 are subject to authorisation.

Competent Authorities: The authority or authorities or bodies established by the Member States to carry out their obligations arising from the REACH system.

Computer modelling: Using a computer to predict effects of chemicals. Normally the model is based on data collected on actual occurrences. Helps to avoid animal testing.

Deadlines: Existing substances will be phased into REACH over 11 years, with the highest tonnage levels to be phased in first.

Downstream user: Companies that use substances professionally or industrially (on their own, in preparations). Example: a manufacturer who mixes different chemicals to make ink, or uses the ink to print leaflets.

Endocrine disrupters: Substances of very high concern that mimic or inhibit the effects of hormones. Subject to Authorisation on a case-by-case basis. Many of these substances are also CMRs.

Epidemiological studies: Studies of public or occupational health. Cohort studies compare the health status of a group of people that have been exposed to the same environmental factor (e.g. a chemical) with a control group. Case-control-studies look at a group of people that have developed certain symptoms (e.g. a specific kind of cancer) to establish whether they have been exposed to certain environmental factors to a greater extent than other people.

European Chemicals Bureau: A part of the Joint Research Centre (JRC) in Ispra, doing a lot of the Commission's scientific-technical work under the current legislation. Will prepare the ground for the new Agency that will then manage the REACH system.

Evaluation: Qualitative assessment of registration dossiers.

Existing chemicals: Chemicals that were reported to be on the market in 1981, when the requirement to notify new chemicals entered into force. There are about 100,000 existing chemicals. According to estimations, some 30,000 of them will be subject to registration in REACH.

Exposure: To come into contact with a substance. The amount of a substance someone comes into contact with is often modelled on a computer.

GHS: Globally Harmonised System for classification and labelling of chemicals.

HPV: High production volume (substances produced annually in volumes of more than 1,000 tonnes).

IFCS: Intergovernmental Forum on Chemicals Safety.

Intermediates: Chemicals that are used up in the process of making other chemicals.

In vitro testing: Studies done with cell or tissue cultures (as opposed to in vivo testing, where live animals are used).

New chemicals: Chemicals that have been placed on the market since 1981. These have to be notified to the Competent Authorities under the current EU chemicals legislation. There are around 3,400 'new' chemicals currently on the market.

OECD: Organisation for Economic Co-operation and Development.

PBTs: Substances of very high concern that are persistent (difficult to break down), bio-accumulative (accumulate in our bodies) and toxic. Subject to authorisation.

PIC: The Rotterdam Convention on Prior Informed Consent sets up a system to control international trade in certain hazardous substances.

Product and process oriented research and development (PPORD): Substances used in PPORD will have time limited exemptions from testing requirements.

R & D: Research and development.

Registrant: The manufacturer or the importer submitting a registration.

Registration: The first administrative step of REACH. The manufacturers and importers submit information in a standardised format, to demonstrate that they are managing their chemicals safely.

Risk: The risk posed by a substance depends on hazard (the intrinsic properties of the substance) and exposure.

SMEs: Small and medium sized enterprises.

Substances in articles: Substances of concern that are released in significant amounts from articles during use or disposal and so give rise to significant risks, will generally have to be registered.

Substitution: Avoiding to use a hazardous substance by replacing it with another substance (a substitute) or by changing production methods.

Sustainable development: Development that meets the needs of the present without jeopardising the needs of future generations. Sustainable development includes striking the right balance between environmental, social and economic concerns.

Technical Expert Working Groups: Eight working groups consisting of stakeholder experts were convened in the winter of 2001/2002 to discuss and investigate technical issues.

Tonnage threshold: Volume based criteria for different requirements under REACH, formulated as "X tonnes /year per manufacturer/importer". Will affect registration deadlines.